FDA 21 CFR 812 IDE 中文简译 (fda临床试验规定).pdf

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1、PART812—INVESTIGATIONALDEVICEEXEMPTIONS调查的机械豁免SubpartA—GeneralProvisionsSec.812.1Scope.范围812.2Applicability.申请812.3Definitions.定义812.5Labelingofinvestigationaldevices.标记调查用的机械812.7Prohibitionofpromotionandotherpractices.推广的禁用和实行812.10Waivers.豁免812.18Importandexportrequirements.进口和

2、出口的需求。812.19AddressforIDEcorrespondence.IDE对应的定位SubpartB—ApplicationandAdministrativeAction部分B-申请程序和行政诉讼812.20Application.申请,申請內容812.25Investigationalplan.研究计划812.27Reportofpriorinvestigations.前调查报告(临床前报告)812.30FDAactiononapplications.FDA的申请程序上的行动812.35Supplementalapplications.补充申

3、请812.36Treatmentuseofaninvestigationaldevice.研究机械的处方812.38Confidentialityofdataandinformation.数据和信息的保密性。SubpartC—ResponsibilitiesofSponsors对厂商的责任分部C812.40Generalresponsibilitiesofsponsors.厂商的一般责任812.42FDAandIRBapproval.FDA和IRB的批准812.43Selectinginvestigatorsandmonitors.选择的调查和监控。812

4、.45Informinginvestigators.告知调查。812.46Monitoringinvestigations.监测调查。812.47Emergencyresearchunder§50.24ofthischapter.紧急研究SubpartD—IRBReviewandApproval分部D-IRB的审查和批准812.60IRBcomposition,duties,andfunctions.IRB组成，职责和功能812.62IRBapproval.IRB的批准。812.64IRB’scontinuingreview.IRB的持续检讨812.65[

5、Reserved][修改中]812.66Significantriskdevicedeterminations.重大危险设备的确定SubpartE—ResponsibilitiesofInvestigators研究者的责任812.100Generalresponsibilitiesofinvestigators.研究者的一般责任812.110Specificresponsibilitiesofinvestigators.研究者的特殊责任812.119Disqualificationofaclinicalinvestigator.被取消资格的临床研究者§81

6、2.1Scope.(a)Thepurposeofthispartistoencourage,totheextentconsistentwiththeprotectionofpublichealthandsafetyandwithethicalstandards,thediscoveryanddevelopmentofusefuldevicesintendedforhumanuse,andtothatendtomaintainoptimumfreedomforscientificinvestigatorsintheirpursuitofthispurpose

7、.一）这部分的目的是要鼓励，保护公众健康和安全，道德标准，发现和开发有用的设备用于人类使用的相一致的程度，并为此目的，以保持最佳的自由科学的研究人员在他们的追求自己的目标。(b)Thispartprovidesproceduresfortheconductofclinicalinvestigationsofdevices.Anapprovedinvestigationaldeviceexemption(IDE)permitsadevicethatotherwisewouldberequiredtocomplywithaperformancestandard

8、ortohavepremarketapprovaltobeship